Hi ATL
The reason that I think that there is a possibility that the FDA haven't greenlighted the revised SAP, is that there is nothing to indicate that they have greenlighted it!
In contrast to the evidence that suggests that the MHRA and the EMA have given the go-ahead.
The FDA situation is a Rumsfeldian unknown unknown to me right now.
But if you are right, and that it's the trial sponsor's responsibility to update the US clinical trials site, then why haven't NWBO gotten round to it?
Unless there is nothing to update.
FWIW, my honest opinion is that it is more likely than not, that the FDA did have an objection. But that's only my supposition, and anyone is free to see it otherwise.
If it is the case that at least two of the regulators are playing ball, then that is not too bad. It's what I've been thinking for the last couple of months.
In fact it's really quite good.
Because my prior anxiety was that all the regulators might baulk at the changes.
And I said a couple of months ago that if approval was forthcoming in the UK and the EU, that the FDA would likely eventually fall in line due to patient advocate pressure anyway.
And the company would have had a helluva job actually firing up manufacturing and meeting and servicing 'demand' right across the board, if all three regulators gave approval the same week!
I certainly detect a strong company focus on the UK right now. And I'm sure I'm not the only one seeing that.
And its probably what I'd do as well. Focus on the most achievable jurisdiction first.
If my supposition is wrong, and the FDA is fully on board, then I won't complain about it either!
I'm just too old to do anything other than say it exactly as I see it.
